Depression in dementia Mental and Behavioural Disorders Depression
Conditions
Interventions
The randomised interventions are:
1. Mirtazapine (a NaSSA) + sertraline placebo with normal clinical care
2. Sertraline (an SSRI) + mirtazapine placebo with normal clinical care
3. Mirtazapine placebo
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We have designed this study as a pragmatic trial of effectiveness in routine clinical practice. We wish to minimise exclusions from the study in order to maximise the generalisability of the data generated. The criteria for inclusion are set to be as close to clinical practice as possible. For this reason we do not specify the use of anything other than clinical diagnoses of dementia and depression since standardised instruments (other than the Mini-Mental State Examination [MMSE] as a measure of severity) are not used in routine practice. A detailed characterisation of cases using standardised tools will be completed at the research assessment. We will recruit those in whom a secondary care doctor makes at the point of referral to the RW: 1. A clinical diagnosis of mild to moderate probable or possible Alzheimer's Disease 2. A co-existing depressive illness likely to need treatment with antidepressants 3. Depression should have a duration of more than four weeks
Exclusion criteria
Exclusion criteria: We wish to minimise exclusions. We will exclude from the trial those in whom a secondary care doctor finds at the point of referral to the RW are: 1. Currently taking antidepressants 2 Those with severe dementia (defined as MMSE >7) 3. The case is considered as being too critical to be randomised (e.g. because of suicide risk) 4. Displays absolute contraindications to one or more of the trial treatments 5. Not in another trial 6. Those where there is no identifiable family carer or other informant (e.g. a formal/professional carer who spends sufficient time with the person with dementia to be able to give an informed opinion) to give collateral information We will further exclude from the trial those in whom the RW finds have a Cornell score <8 at the point of randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Depression in dementia - CSDD (Alexopoulos et al 1988) 2. Costs - Client Service Receipt Inventory (CSRI; Beecham et al 2001) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease specific quality of life - DEMQOL and DEMQOL-Proxy (Smith et al 2005) 2. Generic measure of quality of life - interview administered to carer (Coucill et al 2001) EQ-5D (EuroQoL Group 1990) 3. Withdrawal from treatment arm 4. Cognitive impairment - MMSE (Folstein et al 1975) 5. Medication adherence 6. Adverse events 7. Carer mental health - General Health Questionnaire - 12 (GHQ-12; Goldberg et al 1988) 8. Carer quality of life - SF-12 v2 (Ware et al 1996) 9. Carer burden - Zarit Carer Burden Scale (Zarit 1980) | — |
Countries
United Kingdom
Outcome results
None listed